Diabetes Mellitus, Type 2
Conditions
Brief summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
Interventions
DRUGPlacebo
placebo
DRUGBI 187004
BI 187004, dose 2
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes mellitus 2. Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues) 3. Males or post-menopausal or surgically sterilised females 4. Age from 20 and to 70 years 5. HbA1c less or equal to 8.5% 6. BMI 28-40 kg/m2 7. Subjects must be able to understand an comply with study requirements
Exclusion criteria
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance 2. Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg 3. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension 5. Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug 6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy 7. Chronic or relevant acute infections (e.g. HIV, hepatitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events | up to 15 days postdose |
Secondary
| Measure | Time frame |
|---|---|
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) | up to 8 days postdose |
| Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose) | up to 8 days postdose |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) | up to 8 days postdose |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 8 days postdose |
Countries
Germany
Outcome results
None listed